At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.

Find out more: Our approach to R&D

Locations: Siena, Italy / GSK HQ, UK / Wavre, Belgium / Poznan, Poland

Scope

This role offers an exciting opportunity to lead and deliver Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for vaccines. You will manage global CMC regulatory activities across development, registration, and lifecycle management. Collaboration is key, as you’ll work closely with cross-functional teams to ensure compliance and drive innovation. We value candidates who are proactive, detail-oriented, and skilled at navigating complex regulatory environments.

In this role, you will:

• Develop and implement CMC regulatory strategies for vaccines, ensuring compliance with global standards.

• Prepare and review technical regulatory documents to support submissions and lifecycle management.

• Provide regulatory advice to cross-functional teams, including R&D, manufacturing, and quality assurance.

• Lead discussions with regulatory authorities and represent the company in external engagements.

• Identify risks and propose mitigation strategies to ensure smooth regulatory processes.

• Mentor and train team members, fostering a culture of continuous improvement.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s degree in life sciences, pharmacy, chemistry, or a related field.

• Solid and proven experience in CMC regulatory affairs.

• Strong knowledge of global CMC regulatory requirements and drug development processes.

• Proven ability to manage multiple projects and meet deadlines.

• Must be fluent in English (both written and spoken).

Preferred Qualifications:

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

• Master’s degree or PhD in a relevant scientific discipline.

• Regulatory Affairs Certification (e.g., RAPS).

• Experience leading teams and managing complex regulatory submissions.

• Track record of effective negotiation with regulatory agencies.

• Excellent communication and collaboration skills.

• Proficiency in French is a plus.

Please note that relocation support cannot be provided; therefore, only candidates who are already based in the indicated country can be considered.

Closing Date for Applications – 9 November 2025

I candidati interni interessati alla posizione possono applicare attraverso la sezione My Job Opportunities in Workday entro il 9 novembre 2025 COB. Secondo la Policy GSK, questo Job Posting è aperto a tutti i dipendenti a tempo indeterminato e determinato GSK ed ai lavoratori in somministrazione e CW presso GSK Italia. Le domande saranno prese in considerazione solo se il candidato è nella posizione corrente da almeno 12 mesi. Saranno accettate esclusivamente candidature pervenute tramite Workday.

L’inquadramento offerto rispecchierà l’effettiva competenza ed esperienza maturate dal candidato identificato, in relazione alle responsabilità del ruolo proposto.

Ricordiamo che è necessario informare il proprio responsabile nel momento in cui si viene convocati per il colloquio di selezione.

Please take a copy of the Job Description, as this will not be available post closure of the advert. 
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover let